Breaking: ClinCapture embeds AI into the trial's architecture, not on top of it Once billed as the only free, fully validated EDC in the world Clients include Alcon, Abbott, AstraZeneca, Biogen, Edwards Lifesciences Flagship platform rebranded as Captivate ISO 27001 + ISO 9001 certified - 21 CFR Part 11 + GDPR compliant Breaking: ClinCapture embeds AI into the trial's architecture, not on top of it Once billed as the only free, fully validated EDC in the world Clients include Alcon, Abbott, AstraZeneca, Biogen, Edwards Lifesciences Flagship platform rebranded as Captivate ISO 27001 + ISO 9001 certified - 21 CFR Part 11 + GDPR compliant
YesPress Dispatch eClinical Software Las Vegas, NV Est. 2010

ClinCapture

Software for running a clinical trial - data capture, patient outcomes, consent, randomization and coding - folded into one validated cloud, and now taught to build studies with AI.

Category
Clinical / HealthTech
Platform
Captivate
Team
~23 people
Model
B2B SaaS
ClinCapture logo - the winking Captain mark
The winking Captain. A mascot for an industry that rarely lets itself smile - drug development, on a good day, is paperwork with stakes.
The Company // Profile

A small company selling certainty in a business built on doubt

Here is a fact about clinical trials that is either obvious or slightly deranged, depending on how close you sit to one: the protocol - the document that says what a trial will do, to whom, when, and how the data gets recorded - starts life as prose. Someone writes it in a word processor. Then someone else reads that prose and, by hand, configures a database to match it. Then a third person checks whether the database actually matches the prose. Errors, being errors, arrive somewhere in the handoff. This is the machinery that decides whether a drug works, and a meaningful chunk of it is a person retyping a Word document into a form builder.

ClinCapture sells the machinery. It is an eClinical software company - a phrase that means "the software clinical trials run on" - and it has been quietly doing so since 2010, when Ale Gicqueau spun it out of a Silicon Valley clinical-data consultancy called Clinovo. The company is headquartered in Las Vegas, employs somewhere around two dozen people, and counts among its customers a client list that would look padded if it weren't apparently real: Alcon, Abbott, Teleflex, LabCorp, Hologic, AstraZeneca, W.L. Gore, Edwards Lifesciences, Biogen. These are companies that run trials for a living, and they are notoriously hard to sell to, because the cost of a software vendor being wrong is not a refund - it's a regulatory finding.

The thing that makes ClinCapture interesting is not that it built another electronic data capture system. Plenty of people have. It's how it got in the door. For years the company's headline pitch was that ClinCapture was the only free, fully validated EDC in the world - open-source software, given away, in the single most compliance-allergic industry on the planet. That is the sort of sentence that makes a chief financial officer's eye twitch. Free software in drug development sounds like a category error. It worked anyway, and understanding why is most of the story.

"AI should not sit on top of the workflow. It should strengthen the foundation."
Scott Weidley - President & CEO, ClinCapture

What it actually does

Strip away the acronyms and a clinical trial is a data-collection problem wearing a lab coat. You need to enroll patients (and prove they consented), capture what happens to them (from clinics and increasingly from their own phones), randomize who gets what, keep the drug supply straight, translate every reported symptom into a standardized medical vocabulary, and file every document so that when a regulator asks "show me," you can. Historically each of those jobs came from a different vendor, in a different login, speaking a different data format. The polite industry term for the result is "point solutions." The impolite term is "a mess."

ClinCapture's answer is a single platform - now branded Captivate - that tries to do all of it in one place. Electronic data capture with no-code study design. Virtual Data Capture for patient-reported outcomes and electronic consent, aimed at decentralized and hybrid trials where the patient never has to drive to a site. Randomization and trial supply management. Medical coding with a full audit trail. An electronic trial master file so the document pile is inspection-ready rather than inspection-adjacent. The pitch is not "our EDC is better." The pitch is "stop stitching."

The AI turn, and why the framing matters

In March 2026 the company did the thing every software company did in 2026 - it announced AI - but the framing is worth pausing on, because ClinCapture went out of its way to say it was doing the opposite of what everyone else was doing. The fashionable move is to bolt an AI agent on top of an existing product: a chatbot that reads your data, a copilot in the corner. ClinCapture's claim is that it embedded AI into the architecture of the trial itself - an engine that takes a structured protocol and automatically generates and configures large portions of the study, inside the validated environment, before a single patient is enrolled.

CEO Scott Weidley calls the goal "regulated intelligence," which is a genuinely useful phrase for anyone shipping AI into a regulated field: AI that amplifies domain expertise without compromising validation, auditability, or quality. In an industry where "the model made a mistake" can mean "the trial is compromised," the interesting engineering is not the model. It's the guardrails around it - the ISO 27001 and ISO 9001 certifications, the 21 CFR Part 11 and GDPR compliance, the audit trails that let a human stay in the loop and a regulator stay satisfied. ClinCapture's bet is that the boring parts are the product.

By The Numbers
2010
Founded (as Clinovo)
~23
Employees
7+
Products in one platform
$1.5M
Seed funding raised
The Toolkit // Captivate

One login, the whole trial

Data Capture

Captivate EDC

No-code study design with real-time data visibility, form customization and built-in validation.

ePRO / eCOA

Virtual Data Capture

Patient-reported outcomes captured remotely for decentralized and hybrid trials.

Enrollment

eConsent

Digital informed consent and patient enrollment, no clipboard required.

Logistics

Captivate RTSM

Randomization and trial supply management to keep the right drug flowing to the right arm.

Standardization

Captivate Coder

Medical coding with full traceability and dictionary management.

Compliance

Captivate eTMF

Electronic trial master file - inspection-ready document organization.

New // 2026

AI Study Build

Turns a structured protocol into validated digital trial components, automatically.

Human Layer

Professional Services

Biometrics and clinical experts for study design, setup and management.

The Roster

Small vendor, blue-chip logos

A 23-person company does not usually get to name-drop like this. ClinCapture's publicly cited clients skew heavily toward medical devices and pharma - the exact customers who need validation more than they need charm.

AlconAbbott Medical OpticsTeleflex LabCorpHologicAstraZeneca W.L. GoreEdwards LifesciencesBiogen
Where ClinCapture Fits // eClinical Landscape (illustrative)
Medidata
Giant
Veeva Vault
Giant
Oracle
Large
ClinCapture
Nimble
OpenClinica
Niche
Relative market presence, approximate - for orientation, not a scoreboard. ClinCapture competes on flexibility and cost, not headcount.
The Arc

Consultancy to community to platform

2010
Clinovo spins out ClinCapture. Founder Ale Gicqueau, who had built a SAS-based clinical-data consultancy, sets out to bring EDC to small and mid-sized trials via a cost-effective cloud platform and DIY tools.
Early 2010s
The free, validated EDC. Built on open-source roots, ClinCapture is marketed as the only fully validated EDC available for free, and launches a public users-and-developers community.
2014
To the cloud. The EDC is ported to a self-service cloud portal - create, launch and manage studies without local IT. Glenn Keet steps in as CEO.
2018
Seed capital. ~$1.5M raised (part of roughly $3.25M under the Clinovo name), with investors including Healthy Ventures, Lateral Capital and Rock Health Capital.
2025
Enter Captivate. The flagship platform is rebranded, unifying EDC, VDC, RTSM, Coder and eTMF under one name and one private clinical cloud.
Mar 2026
AI in the foundation. CEO Scott Weidley introduces an AI-powered study build engine - phase one of an "intelligent trial" roadmap toward simulation, validation and predictive workflow analysis.
Who It's For

What you can actually do with it

If you run trials (sponsors)

  • Design and launch a study without hiring an IT team to stand up infrastructure
  • Collect patient data from clinics and from patients' own devices
  • Keep consent, randomization and coding in the same validated system
  • Walk into an inspection with an organized eTMF instead of a document hunt

If you run them for others (CROs)

  • Configure studies faster with no-code design and AI-assisted build
  • Support decentralized and hybrid trials without a separate ePRO vendor
  • Give sponsors real-time data visibility instead of end-of-month exports
  • Stay inside 21 CFR Part 11 and GDPR without bolting on compliance later
In Their Words
"This is not about adding AI to EDC. It is about rethinking how trials are designed and building them smarter from the start."
Scott Weidley - on the Captivate AI study build engine, March 2026
"The future is a structured digital construct that can be analyzed, validated, and refined before it impacts real patients."
Scott Weidley - ClinCapture

Quick facts: ClinCapture

ClinCapture is an eClinical software company that builds cloud-based tools for running clinical trials - electronic data capture (EDC), ePRO/eCOA, eConsent, randomization, medical coding, and trial master file management. Born from consulting firm Clinovo and once known as the only free, fully validated open-source EDC in the world, it now markets a unified, AI-augmented platform called Captivate that lets sponsors and CROs design, launch, and manage studies from a single validated cloud system.

Founded
2010
Headquarters
Las Vegas, Nevada, United States
Founders
Ale Gicqueau (Founder, former President & CEO)
Team size
~23 employees
Products
Captivate Platform, Captivate EDC, Captivate VDC (ePRO/eCOA), Captivate VDC (eConsent), Captivate RTSM
Notable
Marketed as the only free, fully validated EDC in the world during its open-source Clinovo era, Built on open-source technology (OpenClinica lineage) with a public users-and-developers community, ISO 27001 and ISO 9001 certified; 21 CFR Part 11 and GDPR compliant

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